Abstract 59P
Background
Ampullary carcinoma (AC) is a rare GI cancer. Disease recurrence rate is about 40% after curative-intent surgery. However, main prognostic factors and adjuvant treatment decision remain a matter of debate.
Methods
The FFCD cohort is a French nationwide prospective cohort, including patients with a resected non-metastatic AC or presenting a locoregional or metastatic disease recurrence within 2 years after tumor resection. The aim of this study is to describe prognostic factors associated with disease-free survival (DFS) after pancreaticoduodenectomy (PD) to propose a user-friendly score to better estimate the risk of recurrence and the benefit of adjuvant therapy.
Results
370 patients resected AC were included between July 2014 and June 2023 in 50 centers. Median age was 68.5, 199 (53.8%) patients were male and 180 (56.1%) had an ECOG-PS 0. Histological subtype was intestinal, pancreatobiliary or mixed/undetermined in 29/41/30% of patients. Adjuvant chemotherapy was performed in 226 (61.1%) patients. Median follow-up of the cohort was 40.6 months. In multivariable analyses, stage III tumor vs other (HR=2.86 [1.89 ;4.17], p<0.0001), poorly vs well differentiated grade (HR=2.51 [1.42;4.43], p=0.002) and non-intestinal vs intestinal subtype (HR=1.58 [1.00;2.49], p=0.052) were associated with shorter DFS. A score based on these 3 parameters divided patients in low (n=83), intermediate (n=133) and high risk (n=96) with a median DFS not reached (NR), 73.1 and 15.2 months and a median overall survival (OS) NR, 86.1 and 38.2 months. Adjuvant chemotherapy was associated with a longer DFS in high-risk (HR=0.37, p=0.001) and in intermediate risk (HR=0.77, p=0.369) while no benefit was observed in low-risk tumors. Finally, after propensity score analysis, adjuvant therapy was associated with longer DFS (HR=0.57, [0.45;0.72] p<0.0001) and OS (HR=0.57, [0.44;0.74], p<0.0001) in the full cohort.
Conclusions
Lymph node invasion, poorly differentiated grade and non-intestinal subtype seem highly prognostic in resected AC. This integrated score using these parameters needs to be confirmed in an external validation dataset to help adjuvant treatment decision making.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Fédération Francophone de Cancérologie Digestive.
Funding
Fédération Francophone de Cancérologie Digestive.
Disclosure
G. Roth: Financial Interests, Personal, Advisory Board: Servier, AstraZeneca, MSD, BMS, Ipsen, Viatris; Financial Interests, Personal, Invited Speaker: Pierre Fabre; Financial Interests, Institutional, Coordinating PI: Genoscience Pharma; Financial Interests, Personal and Institutional, Coordinating PI: Netris pharma, Alpha Tau. A. Pellat: Financial Interests, Personal, Invited Speaker: Servier; Non-Financial Interests, Member, Academic group: Fondation Française de Cancérologie Digestive, Groupe des Tumeurs Neuroendocrines; Other, Invitation to ENETS: Ipsen. C. Gallois: Financial Interests, Institutional, Invited Speaker: Sanofi Genzyme; Financial Interests, Institutional, Advisory Board: Servier, Pierre Fabre, Merck; Financial Interests, Institutional, Other, French congress invitation: MSD; Financial Interests, Institutional, Other, Congress invitation: Amgen. D. Tougeron: Financial Interests, Personal, Advisory Board: AstraZeneca, Sanofi, Amgen, MSD, Roche, Servier, Pierre Fabre, BMS, Bayer; Non-Financial Interests, Member of Board of Directors: Federation Francophone de Cancérologie Digestive. V. Hautefeuille: Financial Interests, Personal, Invited Speaker: Novartis, Merck, Amgen; Financial Interests, Personal, Advisory Board: AAA, Ipsen, Pierre Fabre; Financial Interests, Institutional, Invited Speaker: Deciphera, Esteve. M. Jary: Financial Interests, Personal, Invited Speaker: Pierre Fabre, Servier, MSD, BMS, Amgen; Financial Interests, Personal, Writing Engagement: Incyte; Other, participation to congresses: Pierre Fabre; Other, Participation to congresses: Roche, Bayer; Other, Participation to Congress: Servier, MSD, BMS. M. Muller: Financial Interests, Institutional, Invited Speaker: Servier. O. Bouche: Financial Interests, Personal, Advisory Board: Amgen, Merck, Apmonia Therapeutics, Deciphera, Astellas, Takeda; Financial Interests, Personal, Invited Speaker: Servier, Pierre Fabre, Bayer. J. Taieb: Financial Interests, Personal, Advisory Board: MSD, Astellas, Merck, Servier, Pierre Fabre, Amgen, BMS, Novartis, Pfizer, Sanofi, Rottapharm, Takeda, Financial Interests, Personal, Invited Speaker: Amgen, BMS, Merck, MSD, Novartis; Financial Interests, Personal, Invited Speaker, symposia: Astellas; Financial Interests, Personal, Other, steering Committee of clinical trial: Novartis; Non-Financial Interests, Leadership Role, President of the scientific committee of the ARCAD foundation until end 2022: ARCAD Foundation; Non-Financial Interests, Leadership Role, Chair of the ARCAD pancreas research group: ARCAD Foundation; Non-Financial Interests, Leadership Role, Member of the administrative council, the scientific committee, the executive board and responsible for the international relationships /partnership for FFCD in the Prodige Intergroup: Federation Francophone de Cancérologie Digestive (FFCD); Non-Financial Interests, Other, steering committee of clinical trials: Pfizer, Servier. All other authors have declared no conflicts of interest.
Resources from the same session
54P - BL-B01D1, an EGFR x HER3 bispecific antibody-drug conjugate (ADC), in patients with locally advanced or metastatic biliary tract carcinoma (BTC)
Presenter: Zhihao Lu
Session: Poster session 13
55P - Subsequent anticancer therapy (SAT) analysis from 3-year follow-up of the phase III TOPAZ-1 study of durvalumab plus gemcitabine and cisplatin in biliary tract cancer (BTC)
Presenter: Arndt Vogel
Session: Poster session 13
56P - Multi-omic profiling in cholangiocarcinoma to enable scientific advancement within the DKFZ/NCT/DKTK MASTER study
Presenter: Federico Nichetti
Session: Poster session 13
57P - Integrative analysis of the genomic and transcriptomic landscape identifies ciliary genes as a therapeutic target in bile duct cancer
Presenter: Pietro Carotenuto
Session: Poster session 13
58P - Efficacy and safety of liposomal irinotecan (nal-IRI) plus fluorouracil (5-FU) and leucovorin (LV) versus 5-FU/LV alone for advanced biliary tract cancer (BTC) after progression on gemcitabine-based therapy: A pooled analysis of the NIFTY and NALIRICC trials
Presenter: Changhoon Yoo
Session: Poster session 13
60P - Baseline characteristics and molecular testing of patients with IDH1-mutated cholangiocarcinoma: Initial results from the phase IIIb ProvIDHe study
Presenter: Lorenza Rimassa
Session: Poster session 13
61P - Addressing racial disparities in clinical trials in cholangiocarcinoma
Presenter: Abhinav Vyas
Session: Poster session 13
Resources:
Abstract
62TiP - HERIZON-BTC-302: A phase III study of zanidatamab with standard-of-care (SOC) therapy vs SOC alone for first-line (1L) treatment of human epidermal growth factor receptor 2 (HER2)-positive advanced/metastatic biliary tract cancer (BTC)
Presenter: Teresa Macarulla Mercade
Session: Poster session 13
240P - Efficacy and safety of ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI) in older patients (pts) with HR+/HER2− early breast cancer (EBC) in NATALEE
Presenter: Michael Untch
Session: Poster session 13